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Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19

NCT04360096 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2023-02-03

No results posted yet for this study

Summary

Brief Summary:

SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been reported among those who require mechanical ventilation, despite best available intensive care.

Patients with severe COVID-19 by FDA definition who have not developed respiratory failure be treated with nebulized ZYESAMI™ (aviptadil acetate, a synthetic version of Vasoactive Intestinal Polypeptide (VIP)) 100 μg 3x daily plus Standard of Care vs. placebo + Standard of Care using an FDA 501(k) cleared mesh nebulizer.

The primary outcome will be progression in severity of COVID-19 (i.e. critical OR severe progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other cytokines.

Conditions

  • SARS-CoV 2
  • COVID
  • ARDS
  • ALI
  • Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
  • Dyspnea

Interventions

DRUG

ZYESAMI™ (aviptadil acetate)

Inhaled ZYESAMI™ (aviptadil acetate) 100μg 3x daily by mesh nebulizer

DRUG

Placebo

Normal Saline Inhalation

DEVICE

Nebulized administration of ZYESAMI™ or Placebo

Use of 510(k) cleared mesh nebulizer to deliver investigational product

Sponsors & Collaborators

  • APR Applied Pharma Research s.a.

    lead OTHER

Principal Investigators

  • Jonathan C Javitt, MD, MPH · NeuroRx

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2021-12-15
Completion
2021-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04360096 on ClinicalTrials.gov